MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 01/18/2019

Event Type  malfunction  

Event Description

It was reported that the stoma site of a chait percutaneous cecostomy catheter leaked.The device was required for a study procedure (mdr-2036) for treatment of fecal incontinence and severe, chronic constipation.On (b)(6) 2019, the patient had their previously placed cecostomy catheter exchanged with a cook cecostomy catheter.The target site was the appendix.The new catheter was placed in the operating room at the same time as a malone tract revision procedure.The revision was required due to a previous surgical injury.The initial bowel evacuation was successful.Saline was instilled throughout the duration of time the cecostomy catheter remained in place.On (b)(6) 2019 (4 days post-procedure), the patient experienced stoma site bleeding, stoma site leakage of serous fluid, and fever (unrelated to other diagnosed condition or infection).The dressing around the site was bloody and wet with serious fluid and was changed.It was noted the patient had injury to malone tract/site prior to insertion time that contributed to the cause of this event.The site noted also, ¿revision of malone site due to a previous surgical injury at the time of chait insertion, both of these resulted in [the event(s)]".On (b)(6) 2019 (7 days post-procedure), the patient reported skin excoriation at the catheter site and stoma site infection.The patient subsequently scheduled an appointment with the clinic.The following day, on (b)(6) 2019 (8 days post-procedure), the patient again experienced stoma site leakage.The surgeon documented "fibrinous exudate, no signs of infection".On (b)(6) 2019 (36 days post-procedure), the patient experienced a stoma prolapse and was not treated.On (b)(6) 2019 (155 days post-procedure), the patient experienced granulation tissue at the stoma site and stoma site leakage.The patient was treated with silver nitrate to the granulation tissue.The site noted the cause of the granulation tissue was due to ¿irritation caused to wound¿ and the leakage was due to the tube keeping the site open as well as the presence of the granulation tissue.On (b)(6) 2019 at 6-month follow-up (162 days post-procedure), the patient reported that some days the device empties well and on other days she does not feel she completely empties her bowel.As a result, the chait solution was changed.This report will focus on the leakage that occurred on (b)(6) 2019.The leakage that occurred on (b)(6) 2019 will be captured in a report with patient identifier: (b)(6).The leakage that occurred on (b)(6) 2019 will be captured in a report with patient identifier: (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.A2 - age: 32 years at the time of initial chait placement.A4 - weight: 48 kg/ 105.6 lbs at the time of initial chait placement.D2a - common device name: additional names: exd irrigator, ostomy.D2b - procode: additional product codes: exd.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation on (b)(6) 2019, children's hospital med.Ctr.(united states) had an event involving a chait percutaneous cecostomy catheter (rpn: tdcs-100 device, lot: unknown).It was reported that the patient experienced stoma site leakage eight days post-procedure and was not treated.The surgeon documented ¿fibrinous exudate, no signs of infection¿.Cook became aware of this event on (b)(6) 2023.Reviews of the documentation, including the complaint history, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) identified process step to ensure that nonconforming material does not leave the house.A review of the device history record (dhr) was unable to be completed due to the lack of lot information.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, t_tdcs_rev7.Precautions: instruct patient to read and understand the patient guide titled ¿caring for your temporary & chait trapdoor cecostomy catheters¿ prior to initial catheter introduction.For tract lengths between 6 and 14 cm, see sizing recommendations for appropriate size.If cecostomy tract is greater than 14 cm, a multipurpose drainage catheter should be used.Instructions for use: 3.) insert metal stiffener into catheter to straighten and push catheter through tract over pre-positioned wire guide.(fig.2) once catheter is inserted, remove wire guide and metal stiffener until trapdoor is flush against the access site.(when stiffener and wire guide are removed, the extra coils will reform in the cecum.) 4.) perform contrast injection to confirm catheter position and patency within cecum.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.With a review of the dmr and no device return, cook was not able to find evidence the product was manufactured out of specification or of any nonconforming material in house or in the field.Based on the information provided, no returned product, and the results of our investigation, a definitive cause for the failure could not be established.It is possible the product was not maintained according to provided product labeling.However, this cannot be confirmed without additional information.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16765379
• MDR Text Key: 313672225
• Report Number: 1820334-2023-00459
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100-M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female